If you are the unit manager or finance controller or unit nurse in charge of the endoscopy centre, and your endoscope has been identified with damages,what are your alternatives for repairing it? Where do you send it to for repairs?What is your most important consideration in undertaking repairs to your endoscopic equipment? The endoscopist spends his time on the technical work involving the endoscopy and its various areas of work, while the finance controller of a health center or hospital holds the purse strings in allocating funds to repair equipment. It is very important that both the endoscopist and the financial controller take correlated action to get the endoscope repaired and functioning in excellent condition at all times in the interest of patient and clinician safety, and of establishing optimal efficiency, and in the savings of costs. What then are the centers of repair and maintenance available for endoscopes? Endoscopes can be repaired by sending them back to the Original Equipment Manufacturers (OEM) who provide repairs on all their original equipment. For endoscopes, the market in America has been dominated by at least three big OEMs, namely Olympus America Inc., Pentax Precision Instrument Corp and Fujinon Inc. For many years, OEMs consider themselves to be the only authorized entity to perform repair and refurbishment of their endoscopes, using specific proprietary parts, adhesives, lubricants, specifications, and repair manuals. OEMs must comply with the FDAs Quality System Regulations (QSR).The repair and refurbishment process is subject to regular FDA audits and must comply with Medical Device Reporting (MDR) requirements. In recent years, there have been newer Third Party Repair companies called Independent Service Organisations(ISO). Some ISO's do not work independently by themselves but are aligned to the original OEMs' and so become authorized ISO service partners. Some of these OEMs', notably Pentax and Fujinon provide their authorized ISO service partners with access to proprietary parts, adhesives, training, and repair manuals. In contrast, independent ISO's develop their spares and parts through reverse engineering to make them compatible to the original equipment. The complexity of the repair will determine the cost of repair of the endoscope. So the first step in locating a repair service center is to know whether your repair work is a minor repair or a major repair. Negotiated financial arrangements with repair service centers may be set around fee-for-service, cost-per-procedure and capitated service contracts, with the ISOs competing on cost and convenience, with some providing on-site endoscope replacement during repair. Irrespective of whether you decide to have the endoscope repaired by the OEM, or a OEM authorized-ISO or a third party ISO, patient safety is of prime consideration and must never be compromised. This is your main factor to consider in sending your endoscopic equipment for repair. |
